Class 2 Device Recall

• Date Initiated by Firm: August 04, 2025
• Date Posted: September 11, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2478-2025
• Recall Event ID: 97520
• Product Classification: Spectroscopy instrument - Product Code REM
• Product: Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC,785-ER-ILC.
• Code Information: all codes included in the model numbers.
• FEI Number: 3014813917
• Recalling Firm/ Manufacturer: WASATCH PHOTONICS; 808 Aviation Pkwy Ste 1400; Morrisville NC 27560-6600
• Manufacturer Reason for Recall: Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The failure modes have never been found to occur in these models, whether in the field or factory, but could potentially occur under excessive force or extreme, continuous vibration.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: Notifications will be sent out to all purchasers of affected models. Notification will include an offer of free RMA (return to factory for repair, then shipment back to customer). All repairs will be performed at the site of original manufacture in Morrisville, NC. Customer notifications to be delivered by 31-Aug-2025.
• Quantity in Commerce: 192
• Distribution: U.S.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.